Use of Ibrutinib in 10 Patients with Treatment-Naive or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in Real-World Clinical Practice - A Report from a Single Medical Institution

摘要

In Japan, ibrutinib has been approved as both a front-line and later-line treatment for chronic leukemia/small lymphocytic lymphoma (CLL/SLL). However, little is known about the actual outcomes and adverse events (AEs) associated with the use of ibrutinib in Japanese patients. Objective: The outcomes and AEs of patients treated with ibrutinib in a real-world setting were investigated. Methods: A retrospective cohort study of all patients with CLL/SLL who were treated with ibrutinib at a single institution was conducted. Result: In total,10 patients, including 5 treatment-naive patients (50%), were enrolled. The median follow-up period was 9.8 months (range, 0.2-21.6 months), and the estimated overall response rate (ORR: complete remission plus partial remission) was 60%. The median overall survival and progression-free survival outcomes were not reached. During the follow-up period, 4 patients (40%) had at least one AE and 1 patient (10%) had at least one grade ≥3 AE. Ibrutinib was discontinued in 4 patients (40%) because of AEs in 2 patients (20%), the progression of CLL in 1 patient (10%), and financial reasons in 1 patient (10%). Richters transformation did not occur in any of the cases. Conclusion: The ORR was lower (60%) than that observed in clinical trials. The frequency and severity of AEs were both relatively low, although the discontinuation rate was high (40%). Patient education and medication adherence were considered important.